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FDA authorization offered an additional therapeutic choice against SARS-CoV-2 in the form of a pill (molnupiravir) that can be orally administered.
On 23 December 2021, Food and Drug Administration (FDA) published an emergency use authorization (EUA) for molnupiravir to treat mild-to-moderate COVID-19 in adults with positive outcomes of direct SARS-CoV-2 viral testing, and who are at elevated risk for advancement to severe coronavirus disease, including hospitalization or death. It is indicated for situations in which alternative SARS-CoV-2 treatment options approved by FDA are inaccessible or are not clinically appropriate.
Molnupiravir works by introducing errors into genetic code of coronavirus. This, in turn, prevents further viral replication. Molnupiravir is available by prescription only and must be commenced as soon as possible following coronavirus diagnosis and within five days of symptom appearance. It is not approved for usage in individuals younger than eighteen years of age since it might influence the growth of cartilage and bone.
It is not approved for the pre-exposure or post-exposure prevention of coronavirus disease or for initiation of therapy in individuals hospitalized due to SARS-CoV-2. This is because the benefit of therapy has not been noted in individuals when treatment was initiated following hospitalization due to SARS-CoV-2. It is not an alternative for vaccination in individuals for whom coronavirus vaccination and a booster dose are suggested.
The US-FDA has authenticated 1 vaccine and approved others to prevent coronavirus disease and severe clinical outcomes linked with SARS-CoV-2 infection, including mortality and hospitalization. The EUA was granted based on the data from a randomized clinical trial (MOVe-OUT). This placebo-controlled, double-blind study investigated molnupiravir to manage non-hospitalized adults (age eighteen years and above) having mild to moderate coronavirus disease and were at elevated risk for advancement to severe COVID-19 and/or hospitalization.
Participants had a prespecified chronic medical condition or were at elevated risk of coronavirus disease for other reasons who had not received the SARS-CoV-2 vaccine. The proportion of participants who were hospitalized or died due to any cause during twenty-nine days of follow-up was the major endpoint ascertained. Out of 709 volunteers who were given molnupiravir, 6.8% were hospitalized or died within this time period compared to 9.7% of 699 volunteers who were given a placebo.
Out of volunteers who were given molnupiravir, 1 died during the follow-up period in comparison with 9 volunteers who were given a placebo. Dizziness, nausea, and diarrhea were the adverse effects noted. The drug molnupiravir is orally administered as four 200 milligram capsules every twelve hours for 5 days (forty capsules). It is not approved for use for longer than 5 consecutive days. The efficacy and safety of molnupiravir to treat coronavirus disease continue to be assessed.
US-FDA
Coronavirus (COVID-19) Update: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults
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